RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model 44401 (GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T); Model 44402 (GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T); Model 44403 (GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570; lots 197, 19A, 19F, 19J, 207, 20C, 20H, 20M, 20T).
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- TELEFLEX MEDICAL INC
- Reason for Recall:
- Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
Product Codes/Lot Numbers:
Model 44401 (GTIN: Each: 14026704662552 Box: 24026704662559 Case: 34026704662556; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20T); Model 44402 (GTIN: Each: 14026704662569 Box: 24026704662566 Case: 34026704662563; lots 197, 19A, 19F, 19J, 19P, 19W, 205, 207, 20C, 20H, 20M, 20T); Model 44403 (GTIN: Each: 14026704662576 Box: 24026704662573 Case: 34026704662570; lots 197, 19A, 19F, 19J, 207, 20C, 20H, 20M, 20T).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1294-2021
Related Recalls
Reports received of torn corrugated breathing tubes.
Reports received of torn corrugated breathing tubes.
The firm received reports indicating PTD tip separation during use.